FDA 483 - Zhuhai United Laboratories Co. Ltd. - July 16, 2019

This FDA Form 483 was issued to Zhuhai United Laboratories Co., Ltd. in Zhuhai, China, a manufacturer of sterile and non-sterile APIs and finished drugs. The inspection revealed significant deficiencies in quality control, laboratory procedures, data integrity, and environmental monitoring, particularly concerning out-of-specification investigations and data management. These issues indicate a lack of robust controls to ensure the quality and sterility of drug products.